InfluenzaPhase 4ETOPOMNCT00593502
Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age
A Phase 4 study testing oseltamivir in people with Influenza, run by Hospital District of Southwestern Finland at 1 site in Finland.
Trial summary
The main purpose of this study is to assess the efficacy of early oseltamivir treatment (started within 24 hours of the onset of influenza symptoms) in preventing the development of acute otitis media as a complication of influenza in children aged 1-3 years. Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Influenza
- What is being tested?
- oseltamivir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 409 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2008to Jun 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 1-3 years
- Fever = or > 38.0 C and at least one respiratory symptom OR fever = or > 38.0 C and a positive influenza rapid test
Who cannot join
- Confirmed infection with any other respiratory virus than influenza.
- Suspicion of invasive bacterial infection requiring immediate admission to hospital
- Evidence of a poorly controlled underlying medical condition
- Known immunosuppression (malignancy, transplant, drugs)
- Known allergy to oseltamivir or paracetamol
- Received oseltamivir within 4 weeks
- Participation in another clinical trial with an investigational drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Study of Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age
The main purpose of this study is to assess the efficacy of early oseltamivir treatment (started within 24 hours of the onset of influenza symptoms) in preventing the development of acute otitis media as a complication of influenza in children aged 1-3 years.
- Conditions
- Influenza
- Being tested
- oseltamivir, placebo
- Keywords
- influenza, children, acute otitis media, oseltamivir
- Medical subject headings
- Influenza, Human, Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oseltamivirDrug
Also called Tamiflu
Body weight: ≤ 15 kg, 30 mg twice daily; 15 - ≤ 23 kg, 45 mg twice daily; 23 - ≤ 40 kg, 60 mg twice daily; > 40 kg, 75 mg twice daily, for 5 days
placeboDrug
The dosage of placebo will be similar to the active drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Oseltamivir Receives: Drug: oseltamivir |
| 2 | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of influenza-infected children in whom acute otitis media develops after the start of study medication
Measured: 1-8 days
Secondary outcomes (1)
Time to resolution of fever and other clinical symptoms
Measured: 1-21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital District of Southwestern Finland
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Terho J Heikkinen, MD, Principal investigator, Turku University Hospital, Turku, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593502
- Sponsor's protocol ID
- MV21118
- Other IDs
- EudraCT 2007-004734-17
- Acronym
- ETOPOM
- Status last verified
- Jun 2009
- First submitted
- 4 Jan 2008
- Last updated
- 19 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Heikkinen T, Silvennoinen H, Peltola V, Ziegler T, Vainionpaa R, Vuorinen T, Kainulainen L, Puhakka T, Jartti T, Toikka P, Lehtinen P, Routi T, Juven T. Burden of influenza in children in the community. J Infect Dis. 2004 Oct 15;190(8):1369-73. doi: 10.1086/424527. Epub 2004 Sep 15.
PubMed 15378427Whitley RJ, Hayden FG, Reisinger KS, Young N, Dutkowski R, Ipe D, Mills RG, Ward P. Oral oseltamivir treatment of influenza in children. Pediatr Infect Dis J. 2001 Feb;20(2):127-33. doi: 10.1097/00006454-200102000-00002.
PubMed 11224828Heinonen S, Silvennoinen H, Lehtinen P, Vainionpaa R, Ziegler T, Heikkinen T. Effectiveness of inactivated influenza vaccine in children aged 9 months to 3 years: an observational cohort study. Lancet Infect Dis. 2011 Jan;11(1):23-9. doi: 10.1016/S1473-3099(10)70255-3. Epub 2010 Nov 22.
PubMed 21106443Heinonen S, Silvennoinen H, Lehtinen P, Vainionpaa R, Vahlberg T, Ziegler T, Ikonen N, Puhakka T, Heikkinen T. Early oseltamivir treatment of influenza in children 1-3 years of age: a randomized controlled trial. Clin Infect Dis. 2010 Oct 15;51(8):887-94. doi: 10.1086/656408.
PubMed 20815736
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Study of Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age
- ClinicalTrials.gov ID
- NCT00593502
- Acronym / sponsor ID
- ETOPOM / MV21118
- Conditions
- Influenza
- Keywords
- influenza, children, acute otitis media, oseltamivir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Hospital District of Southwestern FinlandUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Feb 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to assess the efficacy of early oseltamivir treatment (started within 24 hours of the onset of influenza symptoms) in preventing the development of acute otitis media as a complication of influenza in children aged 1-3 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: oseltamivirOseltamivir |
| 2 | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 1-3 years
- Fever = or > 38.0 C and at least one respiratory symptom OR fever = or > 38.0 C and a positive influenza rapid test
Key exclusion criteria (7 listed)
- Confirmed infection with any other respiratory virus than influenza.
- Suspicion of invasive bacterial infection requiring immediate admission to hospital
- Evidence of a poorly controlled underlying medical condition
- Known immunosuppression (malignancy, transplant, drugs)
- Known allergy to oseltamivir or paracetamol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oseltamivirAlso: TamifluBody weight: ≤ 15 kg, 30 mg twice daily; 15 - ≤ 23 kg, 45 mg twice daily; 23 - ≤ 40 kg, 60 mg twice daily; > 40 kg, 75 mg twice daily, for 5 days | Drug | 1 |
| placeboThe dosage of placebo will be similar to the active drug | Drug | 2 |
Primary outcome
Percentage of influenza-infected children in whom acute otitis media develops after the start of study medication
Time frame: 1-8 days
1 secondary outcome
Time to resolution of fever and other clinical symptoms
Time frame: 1-21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2009.
- Background: PubMed 15378427Heikkinen T, Silvennoinen H, Peltola V, Ziegler T, Vainionpaa R, Vuorinen T, Kainulainen L, Puhakka T, Jartti T, Toikka P, Lehtinen P, Routi T, Juven T. Burden of influenza in children in the community. J Infect Dis. 2004 Oct 15;190(8):1369-73. doi: 10.1086/424527. Epub 2004 Sep 15.
- Background: PubMed 11224828Whitley RJ, Hayden FG, Reisinger KS, Young N, Dutkowski R, Ipe D, Mills RG, Ward P. Oral oseltamivir treatment of influenza in children. Pediatr Infect Dis J. 2001 Feb;20(2):127-33. doi: 10.1097/00006454-200102000-00002.
- Derived from this study: PubMed 21106443Heinonen S, Silvennoinen H, Lehtinen P, Vainionpaa R, Ziegler T, Heikkinen T. Effectiveness of inactivated influenza vaccine in children aged 9 months to 3 years: an observational cohort study. Lancet Infect Dis. 2011 Jan;11(1):23-9. doi: 10.1016/S1473-3099(10)70255-3. Epub 2010 Nov 22.
- Derived from this study: PubMed 20815736Heinonen S, Silvennoinen H, Lehtinen P, Vainionpaa R, Vahlberg T, Ziegler T, Ikonen N, Puhakka T, Heikkinen T. Early oseltamivir treatment of influenza in children 1-3 years of age: a randomized controlled trial. Clin Infect Dis. 2010 Oct 15;51(8):887-94. doi: 10.1086/656408.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terho J Heikkinen, MD principal investigator
Turku University Hospital, Turku, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oseltamivir in people with Influenza, run by Hospital District of Southwestern Finland at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of influenza-infected children in whom acute otitis media develops after the start of study medication (time frame: 1-8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00593502, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2009.